Why Quality Culture Matters More Than Ever in MedTech | Build Compliance, Inspire Innovation
Compliance Architects LLC
Why Quality Culture Matters More Than Ever in MedTech | Build Compliance, Inspire Innovation
3:00
Future of Cell & Gene Therapy: Innovations, Challenges & Compliance Insights | Diluks De Silva
Compliance Architects LLC
Future of Cell & Gene Therapy: Innovations, Challenges & Compliance Insights | Diluks De Silva
14:18
EU MDR + FDA QMSR Changes Explained | 2024 Regulatory Update for Medical Devices
Compliance Architects LLC
EU MDR + FDA QMSR Changes Explained | 2024 Regulatory Update for Medical Devices
2:52
Gene Therapy + Medical Devices = The Future of Combination Products
Compliance Architects LLC
Gene Therapy + Medical Devices = The Future of Combination Products
2:28
The Top 3 Challenges Facing the Medical Device Industry Today | Must-Know Insights
Compliance Architects LLC
The Top 3 Challenges Facing the Medical Device Industry Today | Must-Know Insights
2:12
Revolution in Treatment Delivery: Hospital-Based Gene Therapy Explained w/ Diluks De Silva
Compliance Architects LLC
Revolution in Treatment Delivery: Hospital-Based Gene Therapy Explained w/ Diluks De Silva
2:34
Medical Device Industry: Why Quality Culture Matters Interview with Pedro Martinez
Compliance Architects LLC
Medical Device Industry: Why Quality Culture Matters Interview with Pedro Martinez
7:15
Why Choose Compliance Architects®?
Compliance Architects LLC
Why Choose Compliance Architects®?
0:47
Discover the Secrets of Working With Compliance Architects: Insights from Teresa Gorecki
Compliance Architects LLC
Discover the Secrets of Working With Compliance Architects: Insights from Teresa Gorecki
7:50
Applying the Idea of Minimizing Headcount: AI Tips for Small Companies by Teresa Gorecki
Compliance Architects LLC
Applying the Idea of Minimizing Headcount: AI Tips for Small Companies by Teresa Gorecki
2:16
Talent Discussion with Diluks DeSilva: Secrets to Success
Compliance Architects LLC
Talent Discussion with Diluks DeSilva: Secrets to Success
3:59
How Should Companies Cut Costs? Teresa Gorecki Reveals All!
Compliance Architects LLC
How Should Companies Cut Costs? Teresa Gorecki Reveals All!
2:07
Teresa Goecki Shares Insights on the Next Generation of Medicine
Compliance Architects LLC
Teresa Goecki Shares Insights on the Next Generation of Medicine
4:57
Is There a Future for Jobs? Reducing Headcount with AI – Teresa Gorecki Explains
Compliance Architects LLC
Is There a Future for Jobs? Reducing Headcount with AI – Teresa Gorecki Explains
3:26
Teresa Gorecki's Insights on Supply Chain Disruptions
Compliance Architects LLC
Teresa Gorecki's Insights on Supply Chain Disruptions
1:46
How Can Smaller Organizations Thrive with Compliance Architects? Teresa Gorecki Explains!
Compliance Architects LLC
How Can Smaller Organizations Thrive with Compliance Architects? Teresa Gorecki Explains!
4:02
Expanding on CMC Insights from Teresa Gorecki – Shocking Revelations!
Compliance Architects LLC
Expanding on CMC Insights from Teresa Gorecki – Shocking Revelations!
1:23
Teresa Gorecki Discusses New Treatments: What is the Potential?
Compliance Architects LLC
Teresa Gorecki Discusses New Treatments: What is the Potential?
4:30
How to Get Started with Compliance Architects – Expert Tips from Teresa Gorecki
Compliance Architects LLC
How to Get Started with Compliance Architects – Expert Tips from Teresa Gorecki
1:15
Is There a Way to Leverage New AI Tools? Discover the Secrets with Teresa Goercki
Compliance Architects LLC
Is There a Way to Leverage New AI Tools? Discover the Secrets with Teresa Goercki
2:25
How Are You Getting the Talent Pipeline Filled? Exclusive Interview with Diluks DeSilva
Compliance Architects LLC
How Are You Getting the Talent Pipeline Filled? Exclusive Interview with Diluks DeSilva
1:42
Discover how companies leverage Compliance Architects effectively: Insights from Diluks DeSilva
Compliance Architects LLC
Discover how companies leverage Compliance Architects effectively: Insights from Diluks DeSilva
2:20
The Difference Between Different Sized Organizations as We Come Out of the Pandemic Explained!
Compliance Architects LLC
The Difference Between Different Sized Organizations as We Come Out of the Pandemic Explained!
3:02
How To Leverage Compliance Architects: Insights From DIluks DeSilva
Compliance Architects LLC
How To Leverage Compliance Architects: Insights From DIluks DeSilva
2:21
What Are Organizations Doing to Address Client Issues? Teresa Gorecki Explains
Compliance Architects LLC
What Are Organizations Doing to Address Client Issues? Teresa Gorecki Explains
3:30
How Are You Getting the Talent Pipeline Filled? Diluks DeSilva Reveals
Compliance Architects LLC
How Are You Getting the Talent Pipeline Filled? Diluks DeSilva Reveals
1:42
What's Happening in Quality Compliance: Teresa Gorecki Reveals All
Compliance Architects LLC
What's Happening in Quality Compliance: Teresa Gorecki Reveals All
26:27
Improve Automation with Insights from Diluks De Silva: What Advice Do You Have for Clients?
Compliance Architects LLC
Improve Automation with Insights from Diluks De Silva: What Advice Do You Have for Clients?
2:24
Improve Automation with Insights from Diluks De Silva: What Advice Do You Have for Clients?
Compliance Architects LLC
Improve Automation with Insights from Diluks De Silva: What Advice Do You Have for Clients?
2:23
What is the FDA Doing Post-Pandemic? Insights From Teresa Gorecki
Compliance Architects LLC
What is the FDA Doing Post-Pandemic? Insights From Teresa Gorecki
2:22
What is going on in life sciences when it comes to analytics? Insights From Diluks De Silva
Compliance Architects LLC
What is going on in life sciences when it comes to analytics? Insights From Diluks De Silva
6:19
Navigating Talent Acquisition in Pharma - Exclusive Interview with Diluks De Silva
Compliance Architects LLC
Navigating Talent Acquisition in Pharma - Exclusive Interview with Diluks De Silva
18:58
What does building the facility do to your cost of scale? Insights from Teresa Gorecki
Compliance Architects LLC
What does building the facility do to your cost of scale? Insights from Teresa Gorecki
2:03
Discover How to Navigate FDA Regulations Post-Pandemic with Teresa Gorecki
Compliance Architects LLC
Discover How to Navigate FDA Regulations Post-Pandemic with Teresa Gorecki
26:02
Talk to us about current talent trends, and what the industry will need in the next 5 to 10 years?
Compliance Architects LLC
Talk to us about current talent trends, and what the industry will need in the next 5 to 10 years?
7:01
What Does it Mean to "Operationalize the Quality Agreement - from PMWS 2022 - FDA Quality Agreements
Compliance Architects LLC
What Does it Mean to "Operationalize the Quality Agreement - from PMWS 2022 - FDA Quality Agreements
3:20
You Can’t Outsource Responsibility: Managing Quality in a Contract Manufacturing Partnership - FDLI
Compliance Architects LLC
You Can’t Outsource Responsibility: Managing Quality in a Contract Manufacturing Partnership - FDLI
24:40
What Should Companies Concentrate On When Partnering with CMOs and CDMOs? 2022 #PMWS #FDA
Compliance Architects LLC
What Should Companies Concentrate On When Partnering with CMOs and CDMOs? 2022 #PMWS #FDA
4:50
How Does Compliance Architects® Help the Biopharmaceutical Industry Achieve Its Goals?
Compliance Architects LLC
How Does Compliance Architects® Help the Biopharmaceutical Industry Achieve Its Goals?
3:01
How Has Risk Changed for the Biopharmaceutical Industry in Light of Recent Events?
Compliance Architects LLC
How Has Risk Changed for the Biopharmaceutical Industry in Light of Recent Events?
2:03
What Are Some Of The Common Issues and Trends You Are Hearing From Biopharmaceutical Executives?
Compliance Architects LLC
What Are Some Of The Common Issues and Trends You Are Hearing From Biopharmaceutical Executives?
2:12
Introducing Writing for Compliance® - Better Documents. Improved Outcomes.
Compliance Architects LLC
Introducing Writing for Compliance® - Better Documents. Improved Outcomes.
1:33
FDA Compliance Issues and Due Diligence - Discussion from FDLI Enforcement Conference 2021
Compliance Architects LLC
FDA Compliance Issues and Due Diligence - Discussion from FDLI Enforcement Conference 2021
1:01:36
What Are FDA’s Thoughts on Quality Culture?
Compliance Architects LLC
What Are FDA’s Thoughts on Quality Culture?
6:11
A New Quality Culture Paradigm
Compliance Architects LLC
A New Quality Culture Paradigm
4:31
The Scientific Basis of Quality Pulse® - Measuring Quality Culture in Life Sciences
Compliance Architects LLC
The Scientific Basis of Quality Pulse® - Measuring Quality Culture in Life Sciences
7:25
FDA Quality Culture Scenarios VISUALIZED! Exploring the Data with Ken Ray - Quality Pulse®
Compliance Architects LLC
FDA Quality Culture Scenarios VISUALIZED! Exploring the Data with Ken Ray - Quality Pulse®
7:44
How Does Quality Pulse® Align with ICH Q10?
Compliance Architects LLC
How Does Quality Pulse® Align with ICH Q10?
5:09
FDA REMS Partners - "Maintaining Strong Relationships & Contracts Between Sponsors & Vendors” - DGE
Compliance Architects LLC
FDA REMS Partners - "Maintaining Strong Relationships & Contracts Between Sponsors & Vendors” - DGE
46:38
FDA Quality Culture - Two Scenarios - Good vs Bad
Compliance Architects LLC
FDA Quality Culture - Two Scenarios - Good vs Bad
5:03
How Are Life Sciences Companies Measuring Quality Culture? Introducing Quality Pulse®
Compliance Architects LLC
How Are Life Sciences Companies Measuring Quality Culture? Introducing Quality Pulse®
26:11
Medical Product Facility Inspections and COVID-19: What Can Industry Expect Moving Forward?
Compliance Architects LLC
Medical Product Facility Inspections and COVID-19: What Can Industry Expect Moving Forward?
1:03:06
What Makes Quality Pulse® Unique? How is it Different Than Other Tools? Measuring Quality Culture
Compliance Architects LLC
What Makes Quality Pulse® Unique? How is it Different Than Other Tools? Measuring Quality Culture
4:54
Describe the Technical Capabilities of Quality Pulse®  - Quality Culture Diagnostic for Lifesciences
Compliance Architects LLC
Describe the Technical Capabilities of Quality Pulse® - Quality Culture Diagnostic for Lifesciences
2:00
How Does the Interactive / Visual Data Output of Quality Pulse® Help Executives?
Compliance Architects LLC
How Does the Interactive / Visual Data Output of Quality Pulse® Help Executives?
2:21
How is Quality Pulse® Different Than Other Tools on the Market?
Compliance Architects LLC
How is Quality Pulse® Different Than Other Tools on the Market?
2:54
What are the Top 2-3 Skills Required to Support a FDA Virtual Inspections?
Compliance Architects LLC
What are the Top 2-3 Skills Required to Support a FDA Virtual Inspections?
1:59
What Types of Companies Can Benefit from Quality Pulse® Quality Culture Diagnostic for Life Sciences
Compliance Architects LLC
What Types of Companies Can Benefit from Quality Pulse® Quality Culture Diagnostic for Life Sciences
1:28
When Would a Company Consider Using Quality Pulse
Compliance Architects LLC
When Would a Company Consider Using Quality Pulse
3:26
FDA Inspection Readiness Training - Updated for 2022 - Brought to you by Compliance Architects LLC
Compliance Architects LLC
FDA Inspection Readiness Training - Updated for 2022 - Brought to you by Compliance Architects LLC
1:25:46
FDA Quality Culture Diagnostic - What Does Quality Pulse® Help Organizations to Understand?
Compliance Architects LLC
FDA Quality Culture Diagnostic - What Does Quality Pulse® Help Organizations to Understand?
1:14
A New Way to Diagnose and Address Quality Culture in FDA-Regulated Industry - Quality Pulse®
Compliance Architects LLC
A New Way to Diagnose and Address Quality Culture in FDA-Regulated Industry - Quality Pulse®
37:12
Tell the Story of Build Control to FDA Investigators
Compliance Architects LLC
Tell the Story of Build Control to FDA Investigators
1:15
Are You Telling The Story of Regulated Product Manufacturing Control?
Compliance Architects LLC
Are You Telling The Story of Regulated Product Manufacturing Control?
1:26
Have You Defined the Correct Critical Control Points?
Compliance Architects LLC
Have You Defined the Correct Critical Control Points?
2:59
FDA’s Case for Quality in Medical Devices and Harmonization of Quality System Regulation - FDLI 2020
Compliance Architects LLC
FDA’s Case for Quality in Medical Devices and Harmonization of Quality System Regulation - FDLI 2020
16:26
Prioritize Principles of Control in FDA Communications
Compliance Architects LLC
Prioritize Principles of Control in FDA Communications
1:06
FDA Inspections are Scary! Are you Ready? Don't Get Spooked by the FDA!
Compliance Architects LLC
FDA Inspections are Scary! Are you Ready? Don't Get Spooked by the FDA!
0:37
Why Do FDA Inspections Go Poorly?
Compliance Architects LLC
Why Do FDA Inspections Go Poorly?
1:04
Do Your Pharmaceutical Batch Records Tell the Full Story?
Compliance Architects LLC
Do Your Pharmaceutical Batch Records Tell the Full Story?
1:25
"The Possibility of Virtual FDA Inspections What You Need to Know" - June 26th, 2020 with Arent Fox
Compliance Architects LLC
"The Possibility of Virtual FDA Inspections What You Need to Know" - June 26th, 2020 with Arent Fox
1:00:10
What is the CRPN Quality Roadmap®?
Compliance Architects LLC
What is the CRPN Quality Roadmap®?
1:13
Risk-Based Quality Planning for FDA-Regulated Industry
Compliance Architects LLC
Risk-Based Quality Planning for FDA-Regulated Industry
56:00
FDA's 1st Quality Culture Diagnostic - Introducing Quality-Pulse from Compliance Architects LLC
Compliance Architects LLC
FDA's 1st Quality Culture Diagnostic - Introducing Quality-Pulse from Compliance Architects LLC
0:53
CRPN Quality Roadmap® - FDA Compliance Risk Management
Compliance Architects LLC
CRPN Quality Roadmap® - FDA Compliance Risk Management
0:51
Why is Measuring Quality Culture Important for FDA Regulated Industry?
Compliance Architects LLC
Why is Measuring Quality Culture Important for FDA Regulated Industry?
0:41
How Do You Measure Quality Culture in FDA Regulated Industry?
Compliance Architects LLC
How Do You Measure Quality Culture in FDA Regulated Industry?
1:33
What Should Quality Executives be Thinking About When it Comes to Risk Management?
Compliance Architects LLC
What Should Quality Executives be Thinking About When it Comes to Risk Management?
1:29
2023 NYE Fireworks Display! Compliance Architects LLC
Compliance Architects LLC
2023 NYE Fireworks Display! Compliance Architects LLC
0:33
About Compliance Architects®:   Consulting & Advisory Services for FDA-Regulated Industry
Compliance Architects LLC
About Compliance Architects®: Consulting & Advisory Services for FDA-Regulated Industry
2:36
Build Control: HACCP for Regulated Manufacturing
Compliance Architects LLC
Build Control: HACCP for Regulated Manufacturing
4:28
About Compliance Architects®:  A Q&A With Jerry Appert
Compliance Architects LLC
About Compliance Architects®: A Q&A With Jerry Appert
2:07
About Compliance Architects®: A Q&A With Michelle Marchok
Compliance Architects LLC
About Compliance Architects®: A Q&A With Michelle Marchok
2:59
About Compliance Architects®:  A Q&A With Jack Garvey
Compliance Architects LLC
About Compliance Architects®: A Q&A With Jack Garvey
4:14
About Compliance Architects®, January 2015
Compliance Architects LLC
About Compliance Architects®, January 2015
2:34